BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KLEENSPEC 590 SERIES DISP. VAGINAL SPECULA

    MDR report key: 1890682 · Received November 1, 2010

    Report

    Report Number
    1316463-2010-00008
    Event Type
    Malfunction
    Date Received
    November 1, 2010
    Date of Event
    October 7, 2010
    Report Date
    October 7, 2010
    Manufacturer
    WELCH ALLYN
    Product Code
    HIB
    PMA / PMN Number
    K941272
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WELCH ALLYN CONTACTED THE COMPLAINANT FOR ADDITIONAL INFORMATION. THE COMPLAINANT STATED WHILE LIFTING THE VAGINAL WALL FOR VISUALIZATION THE BOTTOM BILL BROKE IN A JAGGED, LONGITUDINAL LINE. THE VAGINAL SPECULUM WAS PULLED OUT BY THE HANDLE AND THE BROKEN PIECE REMAINED. A LATERAL VAGINAL WALL LACERATION WAS CAUSED WHEN THE COMPLAINANT REMOVED THE PIECE THAT BROKE OFF THE VAGINAL SPECULUM. THE PATIENT BEGAN BLEEDING AND THE COMPLAINANT PACKED THE AREA AND SENT HER TO A GYN FOR SUTURING. THE COMPLAINANT DID NOT KNOW THE EXTENT OF THE LACERATION AS SHE WAS UNABLE TO VIEW IT SECONDARY TO THE BLEEDING, AND HAD NO FOLLOW UP WITH THE GYN. THE PATIENT IS REPORTEDLY DOING FINE. THE ACTUAL DEVICE HAS BEEN RETURNED TO WELCH ALLYN FOR EVALUATION. THE COMPLAINANT ALSO PROVIDED WELCH ALLYN WITH A DIGITAL PHOTOGRAPH OF THE SPECULUM. RESULTS: VAGINAL SPECULUM.

    Description of Event or Problem · 1

    WELCH ALLYN BECAME AWARE OF AN INCIDENT WHERE A FEMALE PATIENT WAS INJURED WHILE UNDERGOING AN EXAMINATION WHEN THE BOTTOM PIECE OF THE KLEENSPEC DISPOSABLE VAGINAL SPECULUM BROKE DIAGONALLY ALONG THE LOWER BILL. THE PATIENT RECEIVED A LACERATION TO THE LATERAL VAGINAL WALL AND REQUIRED SUTURES AS A RESULT OF THE INJURY. THE CUSTOMER DID NOT PROVIDE A PATIENT IDENTIFIER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KLEENSPEC 590 SERIES DISP. VAGINAL SPECULA HIB WELCH ALLYN 59001

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR